Compassionate Use: Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib

NCT ID: NCT03386071

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed to take the trametinib oncedaily dose at approximately the same time each day, by mouth with approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

Detailed Description

The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed to take the trametinib once daily dose at approximately the same time each day, by mouth with approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

The patient will be provided with complete dosing instructions from his treating physician. If the subject is instructed that if he vomits after taking either of the medications provided under this program, he should not retake the dose. The patient should take the next dose as originally scheduled. If a dose is missed, the patient should not double the next regularly scheduled dose. However, the patient can take the missed dose immediately if the next scheduled dose is at least 12 hours later. If the next scheduled dose is due in less than 12 hours, the patient is instructed to skip the dose and resume dosing the next day at the regular time. Then to take the next dose at the usual time the subject is scheduled to take it. It is not known for how long the subject will remain in the program because each patient may respond differently to the treatment. The length of time the patient will take trametinib therapy will depend on his cancer status and how well he tolerates the drugs. If he experiences severe side effects, he is instructed to call his treating physician immediately. The treating physician may advise him stop compassionate used of trametinib or may advise him to lower the dose. Trametinib may also be stopped completely at his Treating Physician's discretion. The treating physician will use his/her clinical expertise considering the intensity of the adverse effect and/or the results of your laboratory tests to make his/her decision. The Treating Physician may consult with the Novartis Country Pharma Organization Medical Advisor/Director about dose interruptions or modifications.

Conditions

Progressive Metastatic Castrate Resistant Prostate Cancer

Interventions

Trametinib 2 mg

The dosage of trametinib for oral administration is 2mg once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Progressive Metastatic Castrate Resistant Prostate Cancer

Exclusion Criteria

• Absence of Progressive Metastatic Castrate Resistant Prostate Cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Rettig, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensieve Cancer Center

Other Identifiers

Compassionate Use Trametinib

Identifier Type: OTHER

Identifier Source: secondary_id

17-001886

Identifier Type: -

Identifier Source: org_study_id